FDA Ordered Stop of Seven Tobacco Products

The FDA has issued orders that seven dissolvable tobacco products, manufactured by Star Scientific, Inc. are not substantially equivalent (NSE) to the predicate products submitted by the manufacturer. An NSE order means these products cannot be sold, marketed, or distributed in interstate commerce in the future without submitting new applications to the FDA.

Additionally, the agency is now actively reviewing, and will continue to issue decisions, on provisional tobacco products. FDA will also continue to prioritize those tobacco products based on their potential to raise different questions of public health.